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Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00106821
  Purpose

The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Tiotropium Bromide Inhalation Powder
 Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Tiotropium Tiotropium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: An 8 Week Randomized, Placebo Controlled, Double-Blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent With Chronic Obstructive Pulmonary Disease

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment

Secondary Outcome Measures:
  • FEV1 AUC0-3 after single dose, 4 weeks of treatment, peak FEV1 on each test day, trough FEV1 at weeks 4 & 8, FVC trough (weeks 4 & 8), peak and AUC(0-3) (on all test days), FEV1 and FVC at all time points, rescue albuterol use, dyspnea SOP questionnaire

Estimated Enrollment: 180
Study Start Date: June 2004
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of African descent
  • 40 years of age or older
  • Diagnosis of COPD
  • History of smoking at least one pack per day for at least 10 years
  • Currently experiencing shortness of breath at least with exertion

Exclusion Criteria:

  • Asthma
  • Recent myocardial infarction or hospitalization for congestive heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106821

Locations
United States, Alabama
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
Cooper Green Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
VA Greater Los angeles Health Care Systems
Sepulveda, California, United States
David Geffen School of Medicine
Los Angeles, California, United States
United States, Connecticut
Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
Yale Univ. Pulmonary and Critical Care Medicine
WEst Haven, Connecticut, United States
United States, Florida
Bay Pines V. A. Medical Center
St. Petersberg, Florida, United States
Emerald Coast Research Associates
Panama City, Florida, United States
United States, Louisiana
LSU MC-Sheveport
Shreveport, Louisiana, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
United States, New York
Bronx VA Medical Center
Bronx, New York, United States
United States, North Carolina
Brody School of Medicine, East Carolina University
Greenville, North Carolina, United States
United States, Pennsylvania
Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
Attention: Amir Sharafkhaneh, M.D.
Houston, Texas, United States
VAMC Houston
Houston, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 205.294
Study First Received: March 31, 2005
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00106821  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Lung Diseases
 Respiration Disorders
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009



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